Cleared Traditional

SLIDEX STREPTO-KIT

K905020 · Vitek Systems, Inc. · Microbiology
Jan 1991
Decision
82d
Days
Class 1
Risk

About This 510(k) Submission

K905020 is an FDA 510(k) clearance for the SLIDEX STREPTO-KIT, a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on January 28, 1991, 82 days after receiving the submission on November 7, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K905020 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1990
Decision Date January 28, 1991
Days to Decision 82 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GTY — Antigens, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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